NCT07335523

Management of Steatorrhea in Children and Young Adults With Alagille Syndrome After Liver Transplantation

A Phase 2 Treatment Withdrawal Clinical Trial of a Bicarbonate-Buffered, Enteric-Coated Pancreatic Enzyme Supplement for the Management of Steatorrhea in Children and Young Adults With Alagille Syndrome After Liver Transplantation

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Digestive Care, Inc. · Industry
• Sex: All
• Age: 7 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if PERTZYE® works to treat steatorrhea in children and adults with Alagille Syndrome (ALGS) post liver transplant. It will also learn about the safety of PERTZYE®. The main questions it aims to answer are: * Does PERTZYE improve dietary fat absorption? * Does PERTZYE improve stool frequency and consistency? * Does PERTZYE improve abdominal signs and symptoms? * What medical problems do participants have when taking PERTZYE? Researchers will compare the results when participants are taking and stop taking PERTZYE. During the study, participants will: * Consume a high fat diet * Take PERTZYE every day with meals and snacks for up to 4 weeks * Have scheduled checkups by phone or video by clinical staff * Keep a diary of their symptoms and PERTZYE dosing * Collect stool for laboratory testing

Conditions

• Steatorrhea

Interventions

Type	Name	Description
DRUG	Pertzye	PERTZYE (pancrelipase) delayed-release capsules

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-03-01
• Completion: 2028-03-01
• First posted: 2026-01-13
• Last updated: 2026-01-13

Regulatory

• FDA-regulated drug study